| Code | 5532D | ||||||||||
| MA number | 88/0202/20-S | ||||||||||
| Product Form: | kit 5x15 ml (liek.inj.skl.-viacdávková) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| MAH, country: | CIS bio international, France | ||||||||||
| Therapeutic Class: | 88 - RADIOPHARMACA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 12 | ||||||||||
| Container: | multidose glass vial | ||||||||||
| Route of admin.: | Intravenous use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10a well-established use application |
| MA issued: | 05.10.2020 |
| Validity: | 05.10.2025 |
| MA renewed: | Renewal application submitted |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| PIL: |
PIL_Pulmocis_kit_05.2024.pdf
|
| SPC: |
SPC_Pulmocis_kit_05.2024.pdf
|
| Safety feature | No |
| Data update: | 06.10.2020 |
